Safety & Efficacy of Adipose-Derived Regenerative Cells in the Treatment of Chronic Myocardial Ischemia (ATHENA II)

Cytori Therapeutics

Status and phase: Completed; Phase 2

Conditions: Myocardial Ischemia

Treatments: Device: Placebo; Device: Celution System

Study type: Interventional

Funder types: Industry

Identifiers

NCT02052427

ATHENA II

Details and patient eligibility

About

This is a prospective, randomized, placebo-controlled, double blind safety and efficacy clinical trial.

Full description

To assess the safety and efficacy of Adipose-Derived Regenerative Cells (ADRCs) delivered via an intramyocardial route in the treatment of chronic ischemic heart disease in patients who are not eligible for percutaneous or surgical revascularization.

Enrollment: 3 patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Males or females > 20 and < 80 years of age
2. Significant multi-vessel coronary artery disease not amenable to percutaneous or surgical revascularization
3. CCS Angina Functional Class II-IV and/or NYHA Stages of Heart Failure Class II or III
4. On maximal medical therapy for anginal symptoms and/or heart failure symptoms
5. Hemodynamic stability (SBP ≥ 90 mm/Hg, HR <110)
6. Ejection fraction ≥ 20% and ≤ 45%
7. Inducible ischemia using an objective assessment of ischemia within 1 year of screening (i.e. exercise ECG changes, SPECT)
8. Left ventricular wall thickness ≥ 8 mm at the target site for cell injection

Exclusion criteria

1. Atrial fibrillation or flutter without a pace maker that guarantees a stable heart rate
2. Unstable angina
3. LV thrombus, as documented by echocardiography
4. Planned staged treatment of CAD or other intervention on the heart
5. Platelet count < 100,000/mm3
6. WBC < 2,000/mm3
7. TIA or stroke within 90 days prior to randomization
8. ICD shock within 30 days prior to randomization
9. Any condition requiring immunosuppressive medication
10. A high-risk acute coronary syndrome (ACS) or a myocardial infarction in the 60 days prior to randomization
11. Revascularization within 60 days prior to randomization
12. Inability to walk on a treadmill except for class IV angina patients who will be evaluated separately
13. Hepatic dysfunction, as defined as aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) > 1.5 times the upper limit of normal range (x ULN)
14. Hemoglobin ≤ 10.0 g/dL

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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3 participants in 2 patient groups, including a placebo group

ADRCs

Experimental group

Description:

Adipose-Derived Regenerative Cells (ADRCs) processed by the Celution System: * 0.8 x 10\^6 cells/kg body weight (not to exceed 80.0 x 10\^6 cells) * Delivered via the MYOSTAR™ Injection Catheter in 15 intramyocardial injections

Treatment:

Device: Celution System

Placebo

Placebo Comparator group

Description:

Placebo - Physiological Solution * Inactive substance (Lactated Ringers + autologous blood) * Delivered via the MYOSTAR™ Injection Catheter in 15 intramyocardial injections

Treatment:

Device: Placebo